Product Detail

Product Description Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0715-58

Recall Number D-690-2013

Classification Class III

Code Info Lot #s: 33802107A, 33802108A, Exp 9/13; 33802109A, 33802110A, 33802111A, 33802112A, Exp10/13; 33802560A, Exp 1/14.

Product Distributed Qty 59,240 Cartons

Reason For Recall Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

Event Detail

Event Id 64643

Product Type Drugs

Status Ongoing

Recalling Firm
Teva Pharmaceuticals USA, Inc.
City Sellersville
State PA
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-03-15

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide and Puerto Rico